Exercise and Vascular Function in Postmenopausal Females With Hypertension
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Systolic BP equal to or greater than 130 mmHg and diastolic BP equal to and greater than 80 mmHg
- 55-80 years old
- Post-menopausal female
- Early or intermediate chronotype
- Able to walk without assistance
Exclusion Criteria:
- Habitually physically active defined as 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week
- Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or pulmonary hypertension
- Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral arterial disease, stroke, coronary artery disease, renal disease, secondary hypertension, chronic venous insufficiency or deep vein thrombosis within last 6 months
- Cancer within last 5 years
- Body mass index >39 kg/m2
- Current smoking or vaping
- Evening shift work
- Evening chronotype
Sites / Locations
- Michigan State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Morning (AM)
Evening (PM)
Arm Description
Before 10 A.M.
After 4 P.M.
Outcomes
Primary Outcome Measures
Nocturnal systolic blood pressure (BP)
Reduction in systolic nocturnal BP (exercise-control)
Secondary Outcome Measures
Early post-exercise hypotension
Post-exercise systolic BP (exercise - control)
Endothelial function
Flow mediated dilation of the brachial artery
Microvascular function
Rapid onset vasodilation of the popliteal artery
Full Information
NCT ID
NCT05597033
First Posted
October 25, 2022
Last Updated
September 6, 2023
Sponsor
Michigan State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05597033
Brief Title
Exercise and Vascular Function in Postmenopausal Females With Hypertension
Official Title
The Effects of Exercise Time of Day on Blood Pressure and Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The treatment of high blood pressure, or hypertension, is multifaceted and can include pharmacological therapies (i.e., medications) and lifestyle modifications such as physical activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms, has recently been used with hypertension medications and has been shown to be effective at lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically, taking medications in the evening was shown to be more effective than morning medication routines. Little information is available about the effectiveness of chronotherapy combined with exercise (i.e., planned physical activity) interventions in older adults with hypertension. The purpose of this study is to examine how exercise performed in the morning and early evening affects blood pressure and other measures of blood vessel health in postmenopausal females with hypertension.
Detailed Description
Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise. Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate the effect of evening exercise on BP and other measures of vascular function in older females with hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning (AM)
Arm Type
Experimental
Arm Description
Before 10 A.M.
Arm Title
Evening (PM)
Arm Type
Experimental
Arm Description
After 4 P.M.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
walking and handgrip exercise
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
seated rest
Primary Outcome Measure Information:
Title
Nocturnal systolic blood pressure (BP)
Description
Reduction in systolic nocturnal BP (exercise-control)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Early post-exercise hypotension
Description
Post-exercise systolic BP (exercise - control)
Time Frame
30 minutes
Title
Endothelial function
Description
Flow mediated dilation of the brachial artery
Time Frame
24 hours
Title
Microvascular function
Description
Rapid onset vasodilation of the popliteal artery
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Ambulatory blood pressure
Description
Systolic and diastolic BPs over a 24-hr period
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Systolic BP equal to or greater than 130 mmHg without BP medication or greater than 120 mmHg with medication and diastolic blood pressure equal to and greater than 80 mmHg
55-80 years old
Post-menopausal female
Early or intermediate chronotype
Able to walk without assistance
Exclusion Criteria:
Habitually physically active defined as 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week
Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or pulmonary hypertension
Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral arterial disease, stroke, coronary artery disease, renal disease, secondary hypertension, chronic venous insufficiency or deep vein thrombosis within last 6 months
Cancer within last 5 years
Body mass index >39 kg/m2
Current smoking or vape
Evening shift work
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Slade, PhD
Phone
517-884-3351
Email
jslade@msu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katharine Currie, PhD
Phone
517-432-4073
Email
curriek4@msu.edu
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill McMahon, PhD
Phone
517-884-3351
Email
jslade@msu.edu
First Name & Middle Initial & Last Name & Degree
Katharine Currie, PhD
Phone
517-432-4073
Email
curriek4@msu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise and Vascular Function in Postmenopausal Females With Hypertension
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